ArticleBMC cancer2018
A web tool for designing and conducting phase I trials using the continual reassessment method.
Article in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed.
- A novel model of the continual reassessment method in Phase I trial.Scientific reports · 2023Article
- Practical implementation of the partial ordering continual reassessment method in a Phase I combination-schedule dose-finding trial.Statistics in medicine · 2022Article
- A Road Map for Designing Phase I Clinical Trials of Radiotherapy-Novel Agent Combinations.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Review
- Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic.BMC medical research methodology · 2022Article
- Operating characteristics are needed to properly evaluate the scientific validity of phase I protocols.Contemporary clinical trials · 2021Article
- A simulation-free approach to assessing the performance of the continual reassessment method.Statistics in medicine · 2020Article
- Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs.BMC medicine · 2020Article
- Designing and evaluating dose-escalation studies made easy: The MoDEsT web app.Clinical trials (London, England) · 2020Article
- Coherence principles in interval-based dose finding.Pharmaceutical statistics · 2020Article
- A web application for the design of multi-arm clinical trials.BMC cancer · 2020Article
- Evaluation of irrational dose assignment definitions using the continual reassessment method.Clinical trials (London, England) · 2019Article
- How to design a dose-finding study using the continual reassessment method.BMC medical research methodology · 2019Article
- The Impact of Early-Phase Trial Design in the Drug Development Process.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
backgroundBroad implementation of model-based dose-finding methods, such as the continual reassessment method (CRM), has been limited, with traditional or modified 3 + 3 designs remaining in frequent use. Part of the reason is the lack of reliable, easy-to-use, and robust software tools for designing and implementing more efficient designs.
resultsWith the aim of augmenting broader implementation of model-guided methods, we have developed a web application for the Bayesian CRM in the R programming language using the Shiny package. The application has two components, simulation and implementation. Within the application, one has the ability to generate simulated operating characteristics for the study design phase, and to sequentially provide the next dose recommendation for each new accrual or cohort based on the current data for the study implementation phase. At the conclusion of the study, it can be used to estimate the maximum tolerated dose (MTD). The web tool requires no programming knowledge, and it is free to access on any device with an internet browser.
conclusionsThe application provides the type of simulation information that aid clinicians and reviewers in understanding operating characteristics for the accuracy and safety of the CRM, which we hope will augment phase I trial design. We believe that the development of this software will facilitate more efficient collaborations within study teams conducting single-agent dose-finding trials.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.